July 23, 2016
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Side Effects


Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

ERIVEDGE capsule was administered as monotherapy at doses ≥ 150 mg orally daily in four open-label, uncontrolled, dose-ranging or fixed single dose clinical trials enrolling a total of 138 patients with advanced basal cell carcinoma (BCC). The median age of these patients was 61 years (range 21 to 101), 100% were White (including Hispanics), and 64% were male. The median duration of treatment was approximately 10 months (305 days; range 0.7 to 36 months); 111 patients received ERIVEDGE for 6 months or longer.

The most common adverse reactions ( ≥ 10%) were muscle spasms, alopecia, dysgeusia, weight loss, fatigue, nausea, diarrhea, decreased appetite, constipation, arthralgias, vomiting, and ageusia (Table 1).

Table 1: Adverse Reactions Occurring in ≥ 10% of Advanced BCC Patients

MedDRA Preferred Term2 All aBCC1 Patients
(N = 138)
All Grades3 (%) Grade 3 (%) Grade 4 (%)
Gastrointestinal disorders
  Nausea 42 (30.4%) 1 (0.7%) -
  Diarrhea 40 (29.0%) 1 (0.7%) -
  Constipation 29 (21.0%) - -
  Vomiting 19 (13.8%) - -
General disorders and administration site conditions
  Fatigue 55 (39.9%) 7 (5.1%) 1 (0.7%)
  Weight loss 62 (44.9%) 10 (7.2%) -
Metabolism and nutrition disorders
  Decreased appetite 35 (25.4%) 3 (2.2%) -
Musculoskeletal and connective tissue disorders
  Muscle spasms 99 (71.7%) 5 (3.6%) -
  Arthralgias 22 (15.9%) 1 (0.7%)
Nervous system disorders
  Dysgeusia 76 (55.1%) - -
  Ageusia 15 (10.9%) - -
Skin and subcutaneous tissue disorders
  Alopecia 88 (63.8%) - -
1aBCC = Advanced Basal Cell Carcinoma.
2MedDRA =Medical Dictionary for Regulatory Activities.
3Grading according to NCI-CTCAE v3.0.


In clinical trials, a total of 3 of 10 pre-menopausal women developed amenorrhea while receiving ERIVEDGE [see Nonclinical Toxicology].

Laboratory Abnormalities

Treatment-emergent Grade 3 laboratory abnormalities observed in clinical trials were hyponatremia in 6 patients (4%), hypokalemia in 2 patients (1%), and azotemia in 3 patients (2%).

Read the Erivedge (vismodegib) Side Effects Center for a complete guide to possible side effects


Clinically relevant pharmacokinetic interactions are not expected between vismodegib and a substrate, inducer or inhibitor of cytochrome 450 enzymes or an inhibitor of P-glycoprotein (P-gp) or between vismodegib and gastric pH elevating agents [see CLINICAL PHARMACOLOGY].

Read the Erivedge Drug Interactions Center for a complete guide to possible interactions

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 4/27/2016

Side Effects

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